The EU Data Act: A Structural Re-engineering of HealthTech Data Governance, Business Models and Regulatory Risk

healthcare.digital September 29, 2025
Nelson Advisors

Foundational Regulatory Framework and Applicability

The European Union Data Act (Regulation (EU) 2023/2854) represents a paradigm shift in the governance of machine-generated data within the European data economy. As a central pillar of the EU’s Digital Decade objectives, the Data Act’s primary goal is to foster competition and innovation by mitigating technical and contractual lock-ins that historically granted manufacturers exclusive control over the data generated by connected products. This mandate has profound implications for the global Health Technology (HealthTech) sector.

The regulation applies broadly across all sectors, specifically targeting data generated by “Connected Products” and “Related Services” placed on the EU market, irrespective of the data holder’s location (extraterritorial reach).

The Data Act came into force on January 11, 2024....

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